HD OXANDROLONE TABLET

 COMPOSITION: 

Each tablet contains: Oxandrolone 10 mg

 INDICATIONS: Certain cases of disseminated breast cancer in women. Osteoporosis due to androgen deficiency in hypogonadal males. 

CONTRA-INDICATIONS: Not intended for use in children. Known or suspected prostatic carcinoma and mammary carcinoma in the male. Not intended for use in female patients other than those with disseminated breast cancer. Contraindicated in nephrosis or the nephrotic phase of nephritis, cardiac and renal failure, hypercalcaemia, oedema, jaundice, liver disease with impaired bilirubin excretion, testicular and hepatic carcinoma. 

DOSAGE AND DIRECTIONS FOR USE: Oxandrolone should be taken orally per day in divided doses. Adult dose: 5-10 mg every day.

 SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Virilisation which appears in sensitive women as hoarseness, acne, hirsutism, and increased libido; in prepubertal boys as an increased frequency of erections and phallic enlargement, and in girls as an increase of pubic hair and clitoral hypertrophy. Hoarseness may be the first symptom of vocal change which may end in a long-lasting, sometimes irreversible deepening of the voice. 

OTHER ADVERSE REACTIONS MAY INCLUDE: Oligospermia and decreased ejaculatory volume; Suppression of ovarian activity, atrophy of the breasts and endometrial tissue. Amenorrhoea and inhibition of spermatogenesis. Water and salt retention. Premature epiphyseal closure. If signs of virilisation develop, treatment should be discontinued. Increase in nitrogen retention and skeletal weight; Oedema; Increased vascularity of the skin; Increased growth of the bone; Elderly males may become over-stimulated. PATIENTS WITH THE FOLLOWING CONDITIONS SHOULD BE MONITORED: Latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions), since anabolic steroids may induce salt and fluid retention; diabetes, since anabolic steroids may improve the glucose tolerance and decrease the need for insulin or other antidiabetic drugs; incomplete statural growth, since anabolic steroids in high dosages may accelerate epiphyseal closure; skeletal metastases, since anabolic steroids may induce hypercalcaemia and hypercalciuria in these patients. 

INTERACTIONS: Oral hypoglycaemic agents: may inhibit the metabolism of oral hypoglycaemic agents which may require adjustments of dosage. Anti coagulants: Patients on anticoagulants should be carefully monitored during anabolic steroid therapy as anabolic steroids may increase sensitivity to oral anticoagulants. Patients should be monitored regularly during anabolic steroid therapy, particularly during initiation and termination of therapy. 

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See "Side-effects and special precautions". Treatment is symptomatic and supportive. 

Over dosage:

Signs and symptoms of over dosage are those associated with the known effects of the drug. See adverse reactions section.

Treatment is symptomatic and supportive. Evacuate stomach contents by emesis and, if indicated, lavage, taking care to

prevent aspiration. Monitoring of liver function is advised.

Precautions:

Elevated liver enzymes and in extreme cases hepatic liver dysfunction may occur, 17 alpha alkylated androgens may cause

cholestatic hepatitis and jaundice, particularly with larger dosages or prolonged treatment. Liver function should be monitored

for changes including serum bilrubin, aspartete aminotransferase (AST), alanine aminotransferase (ALT) and alkaline

phosphatise (AP).

Edema may be increased in patients on concurrent adrenal cortical steroid or ACTH therapy. Anabolic steroid hormones may

increase low density lipoproteins (LDL) and decrease high density lipoproteins (HDL). Lipids levels generally return to normal

upon discontinuation of treatment.

PRESENTATION:

Oxandrolone 10 tablets packed in blister & 10 blister packed in carton along with package insert .

STORAGE INSTRUCTIONS:

Oxandrolone should be stored at controlled room temperatures below 25°C and protected from light. If it has expired or is

damaged, return it to your pharmacist for disposal.

Keep out of reach of children.